BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 21794843 · Received April 8, 2025

    Report

    Report Number
    9710014-2024-000598
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    April 18, 2024
    Report Date
    April 8, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: DEVICE INVESTIGATION DID NOT REVEAL ANY DEVICE DEFECT OR DAMAGE, WHICH HAS BEEN PRESENT WHILST IMPLANTED. MECHANICAL DAMAGES FOUND DURING INVESTIGATION ARE ATTRIBUTABLE TO THE REMOVAL SURGERY. THIS IS AS EXPECTED AS THE DEVICE WAS EXPLANTED DUE TO LOSS OF HEARING BENEFIT, CRACKLING AND POPPING SOUNDS, 12 YEARS AFTER IMPLANTATION, FOR UNKNOWN REASONS, AND LIKELY SECONDARY TO CLINICAL FACTORS. FACIAL NERVE STIMULATION WAS ALSO REPORTED, WHICH IS A KNOWN UNDESIRED SIDE EFFECT OF COCHLEAR IMPLANTATION, AND THE RECIPIENT'S COCHLEAR MALFORMATION MAY INCREASE ITS RISK. FURTHERMORE, IN SITU MEASUREMENTS SHOW TWO CHANNELS INVOLVED IN A SHORT CIRCUIT DUE TO UNDETERMINED REASONS. THIS IS A FINAL REPORT. CORRECTION: THE VALUE IN THE FIELD "MFR REPORT NUMBER" GIVEN IN THE PREVIOUS REPORTS WERE WRONG AND IT HAS BEEN CORRECTED IN THE PRESENT REPORT, WHICH REFLECTS THE FINAL INFORMATION. THE INITIAL REPORT WAS SENT ON 04JUL2024 WITH THE WRONG MFR REPORT NUMBER OF 1066702-2024-000598. THE INITIAL REPORTS WAS SENT WITHIN THE REQUIRED 30DAYS. THE FOLLOW-UP 1 REPORT WAS SENT 13-FEB-2025, ALSO WITH THE WRONG MFR REPORT NUMBER OF 1066702-2024-000598.

    Description of Event or Problem · 0

    AT THE END OF (B)(6) 2024, THE USER EXPERIENCED SIGNIFICANT FACIAL NERVE STIMULATION (FNS) WITH A CRACKLING AND POPPING SOUND. AFTER A 2-DAY BREAK FROM WEARING THE PROCESSOR, THE USER PUT IT BACK ON WITHOUT ANY FURTHER ISSUES. THE USER LATER STARTED EXPERIENCING FNS AGAIN, THIS TIME FOCUSED AROUND THE EYE. DUE TO HEARING CRACKLING/POPPING SOUNDS AND A CONSTANT BUZZ, THE USER STOPPED WEARING THE PROCESSOR. THE AUDIOLOGIST ATTEMPTED RE-MAPPING BUT THE RECIPIENT ENCOUNTERED SEVERE NAS (NONE-AUDITORY STIMULATION). THE USER HAS BEEN RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543288 CONCERTO COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention